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U.S. Department of Health and Human Services

Class 2 Device Recall RESTORIS PST Straight Shell Inserter

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  Class 2 Device Recall RESTORIS PST Straight Shell Inserter see related information
Date Initiated by Firm October 07, 2014
Date Posted December 18, 2014
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-0828-2015
Recall Event ID 69465
510(K)Number K121064  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product RESTORIS PST Straight Shell Inserter
An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Code Information Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075.
Recalling Firm/
Mako Surgical Corporation
2555 Davie Rd Ste 110
Plantation FL 33317-7424
For Additional Information Contact Clayton Odor
Manufacturer Reason
for Recall
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
FDA Determined
Cause 2
Device Design
Action MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods: Email: SYKMakoFLQualitySystems@stryker.com Fax to (954) 423-1547 Mail using enclosed self addressed stamped envelope tp: MAKO Surgical Corporation 2555 Davie Road Ft. Lauderdale, FL 33317 so that the field personnel 1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality. 2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness. 3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event. If you have any questions contact us at (954) 628-1721.
Quantity in Commerce Total 404
Distribution Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION